Shoulder System 04.01.0152Recalls & reported problems
Medacta International SA · Glenoid baseplate Ø24.5x25 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040706391), received between Jan 10, 2020 and Mar 16, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available2
- Break1
- Malposition of Device1
Patient problems
- Bone Fracture(s)5
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
ACROMION FRACTURE DETECTED 5 MONTHS AFTER THE PRIMARY PROCEDURE. NO REVISION SURGERY PLANNED; PHYSIOTHERAPY ONLY.
Patient problems: Bone Fracture(s)
MAUDE report 24603552 ↗MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem
AFTER IMPACTING THE GLENOSPHERE ONTO THE BASEPLATE, THE SURGEON ATTEMPTED TO INSERT THE SCREW, BUT WAS UNSUCCESSFUL. SEVERAL ATTEMPTS, INCLUDING THE USE OF ANOTHER GLENOSPHERE OF THE SAME LOT, ALSO FAILED. THE SURGEON DECIDED TO REPLACE THE BASEPLATE. HOWEVER, DURING ITS REMOVAL, THE GLENOID FRACTURED, NECESSITATING THE IMPLANTATION OF A CTA-TYPE ENDOPROSTHESIS. SUBSEQUENTLY, OUTSIDE THE OPERATIVE FIELD, THE FIT BETWEEN THE GLENOSPHERE AND THE BASEPLATE WAS TESTED AGAIN, BUT EACH TIME THE CENTRAL SCREW WAS TIGHTENED, THE GLENOSPHERE WOULD SLIP OUT OF THE BASEPLATE. DELAY TIME: APPROXIMATELY 30 MINUTES (TOTAL DURATION 1.5 HOURS). NO INFO REGARDING PATIENT`S BONE QUALITY. NO GUIDE WAS USED FORGLENOSPHEREINSERTION.RETENTIVE GLENOSPHERE IMPACTOR (REF 04.01.10.0432) USED.
Patient problems: Bone Fracture(s)
MAUDE report 24454894 ↗InjuryJul 1, 2022Appropriate Device Problem Term/Code Not Available
AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO A GLENOID BONE FRACTURE. THE CAUSE OF THIS BONE FRACTURE IS NOT KNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 14883694 ↗InjurySep 16, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY OF THE GLENOID COMPONENTS DUE TO BONE FRACTURE AND MOBILIZATION, THE PATIENT HAS A POOR BONE QUALITY. PRIMARY PERFORMED ON (B)(6) 2021.
Patient problems: Bone Fracture(s)
MAUDE report 12480570 ↗InjuryNov 25, 2020Break
(B)(6) PATIENT OPERATED WITH REVERSE SHOULDER SYSTEM ON (B)(6) 2020. INTRA-OPERATIVELY, THE GLENOID CONSTRUCT WAS UNSTABLE, THE GLENOID BONE FRACTURED AND THE BASEPLATE MOBILIZED COMPLETELY. THE FRACTURE AND THE BASEPLATE WERE CEMENTED IN ORDER TO FIX THE ISSUE. AFTER 3 DAYS, THE BASEPLATE MOBILIZED AGAIN, THE PATIENT WAS THEN REVISED.
Patient problems: Bone Fracture(s)
MAUDE report 10904260 ↗InjuryJan 10, 2020Malposition of Device; Malposition of Device
ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT SHOULDER. HE RECOGNIZED A BASEPLATE MAL POSITIONING, IT WAS TOO HIGH, IT IMPINGED AND CREATED OSSIFICATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Information
MAUDE report 9573859 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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